Jivi

Product NDC
0026-3950
11-digit product format
000263950
Labeler code
0026
Product ID
0026-3950_15230046-a8a7-4a1c-b279-ae307d278515
Type
PLASMA DERIVATIVE
Nonproprietary name
Antihemophilic Factor (Recombinant) Pegylated-aucl
Dosage form
KIT
Labeler
Bayer HealthCare LLC
Application
BLA125661
Marketing category
BLA
Marketing start
2024-12-02
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Jivi
Listing expiration
2027-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0026-3950-50Jivi1 in 1 BOXKIT113
0026-3950-99Jivi1 in 1 BOXKIT113
0026-4950-01Jivi5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,5 mL4000 [iU] in 5mL13
0026-4950-99Jivi5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,5 mL4000 [iU] in 5mL13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0026-3950-50EA - Each0026-3950a6839f85-6a34-4462-b8d5-22bad26b16d412025-02-10
0026-3950-99EA - Each0026-39502d642d7a-5521-4e58-b89b-0c2189e06b4612025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0026-3950JIVI (ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED-AUCL) KIT [BAYER HEALTHCARE LLC]11Current NDC, 4 package rows20250529_f04e5bd5-d7e2-453b-a407-2616d81a695d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2055659antihemophilic factor (recombinant), PEGylated-aucl 1 UNT InjectionPSNf04e5bd5-d7e2-453b-a407-2616d81a695d13
2055664Jivi 1 UNT InjectionPSNf04e5bd5-d7e2-453b-a407-2616d81a695d13
2055664antihemophilic factor (recombinant), PEGylated-aucl 1 UNT Injection [Jivi]SBDf04e5bd5-d7e2-453b-a407-2616d81a695d13
2055659antihemophilic factor (recombinant), PEGylated-aucl 1 UNT InjectionSCDf04e5bd5-d7e2-453b-a407-2616d81a695d13
2055664Jivi 1 UNT InjectionSYf04e5bd5-d7e2-453b-a407-2616d81a695d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0026-3950-50000263950501 KIT in 1 BOX (0026-3950-50) * 5 mL in 1 VIAL (0026-4950-99) * 5 mL in 1 SYRINGE (0026-0426-05) * 5 mL in 1 VIAL, SINGLE-USE (0026-4950-01) * 5 mL in 1 SYRINGE (0026-0426-15) 1 kit2024-12-02NoNoCurrent
0026-3950-99000263950991 KIT in 1 BOX (0026-3950-99) * 5 mL in 1 VIAL (0026-4950-99) * 5 mL in 1 SYRINGE (0026-0426-05) * 5 mL in 1 VIAL, SINGLE-USE (0026-4950-01) * 5 mL in 1 SYRINGE (0026-0426-15) 1 kit2024-12-02NoNoCurrent
0026-4950-01000264950015 mL in 1 VIAL, SINGLE-USE5 mlHistorical
0026-4950-99000264950995 mL in 1 VIAL5 mlHistorical